Apparatus and methods for maintaining a medical device in a clean and disinfected state, and for cleaning and disinfecting a medical device

ABSTRACT

Sleeves and cases for protecting medical devices against contamination, and methods for cleaning and disinfecting medical devices are provided. The various embodiments enable a single medical device to be used by more than one patient successively while reducing the risk of disease transmission from patient to patient.

INCORPORATION BY REFERENCE TO RELATED APPLICATION

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application claims the benefit of priority of U.S.Provisional Application No. 61/893,822 filed Oct. 21, 2013. Theaforementioned application is incorporated by reference herein in itsentirety, and is hereby expressly made a part of this specification.

TECHNICAL FIELD

The present invention relates to medical devices, and, more particularlyto maintaining cleanliness in such devices and to cleaning such devices.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which can cause anarray of physiological derangements associated with the deterioration ofsmall blood vessels, for example, kidney failure, skin ulcers, orbleeding into the vitreous of the eye. A hypoglycemic reaction (lowblood sugar) can be induced by an inadvertent overdose of insulin, orafter a normal dose of insulin or glucose-lowering agent accompanied byextraordinary exercise or insufficient food intake.

Conventionally, a person with diabetes carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a personwith diabetes normally only measures his or her glucose levels two tofour times per day. Unfortunately, such time intervals are so far spreadapart that the person with diabetes likely finds out too late of ahyperglycemic or hypoglycemic condition, sometimes incurring dangerousside effects. Glucose levels may be alternatively monitored continuouslyby a sensor system including an on-skin sensor assembly. The sensorsystem may have a wireless transmitter that transmits measurement datato a receiver that processes and displays information based on themeasurements. Such sensor systems are sometimes referred to ascontinuous glucose monitors (CGMs).

In certain scenarios, certain components of a CGM may be used by morethan one person. For example, diabetes patients may wish to try a CGMfor a limited time on a trial basis, such as when a patient tests a CGMfor the first time before committing to using one on a more permanentbasis, or when a patient who currently uses a CGM wishes to try a newmodel, brand, etc. In these scenarios, it is desirable for the CGM to becleaned and disinfected before it is passed to each patient in order toaddress concerns associated with blood-borne pathogen diseasetransmission.

SUMMARy

The present embodiments have several features, no single one of which issolely responsible for their desirable attributes. Without limiting thescope of the present embodiments as expressed by the claims that follow,their more prominent features now will be discussed briefly. Afterconsidering this discussion, and particularly after reading the sectionentitled “Detailed Description,” one will understand how the features ofthe present embodiments provide the advantages described herein.

In a first aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the first aspect, certain ofthe present embodiments comprise an enclosure for an electronic medicaldevice. The enclosure comprises a sleeve configured to receive anelectronic medical device having a port. The enclosure further comprisesa first opening in the sleeve sized and configured to allow forinsertion of the electronic medical device into the sleeve and removalof the electronic medical device from the sleeve. The enclosure furthercomprises a second opening in the sleeve, the second opening beinglocated so as to permit access to the port when the electronic medicaldevice is received within the sleeve. The enclosure further comprises afirst cover configured to adhere to a first portion of the sleeve and tocover the first opening. The enclosure further comprises a second coverconfigured to adhere to a second portion of the sleeve and to cover thesecond opening.

In an embodiment of the first aspect, the enclosure further comprises afirst adhesive located and configured to secure the first cover to thesleeve at the first portion.

In an embodiment of the first aspect, the enclosure further comprises asecond adhesive located and configured to secure the second cover to thesleeve at the second portion.

In an embodiment of the first aspect, the first adhesive comprises afirst peel strength, the second adhesive comprises a second peelstrength, and the first peel strength is different than the second peelstrength.

In an embodiment of the first aspect, the first peel strength is greaterthan the second peel strength.

In an embodiment of the first aspect, the first peel strength is greatenough to prevent separation of the first cover from the sleeve withouttearing the sleeve.

In an embodiment of the first aspect, the port is at least one of acharging port or a communication port.

In an embodiment of the first aspect, the communication port is a USBport.

In an embodiment of the first aspect, the sleeve comprises a materialselected from the group consisting of: polyurethane, polyethylene, andlow density polyethylene.

In an embodiment of the first aspect, the sleeve comprises a firstportion comprising a first material and a second portion comprising asecond material.

In an embodiment of the first aspect, the second material has greaterstiffness than the first material.

In an embodiment of the first aspect, the first portion comprises amaterial selected from the group consisting of: polyurethane,polyethylene, and low density polyethylene.

In an embodiment of the first aspect, the second portion comprises amaterial selected from the group consisting of: polycarbonate andacrylonitrile butadiene styrene (ABS).

In an embodiment of the first aspect, the second portion is configuredto provide access to the port.

In an embodiment of the first aspect, the first opening is surrounded bythe first portion, and wherein the second opening is surrounded by thesecond portion.

In an embodiment of the first aspect, the first opening comprises afirst slit that extends in a longitudinal direction, and a second slitthat extends in a transverse direction.

In an embodiment of the first aspect, a first end of the first slitcorresponds to a lengthwise center of the second slit.

In an embodiment of the first aspect, the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.

In a second aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the second aspect, certain ofthe present embodiments comprise a method for reprocessing a reusableelectronic medical device. The method comprises receiving an electronicmedical device from a first user, wherein the electronic medical deviceis contained in a first protective enclosure. The method furthercomprises removing the electronic medical device from the firstprotective enclosure. The method further comprises inserting theelectronic medical device into a second protective enclosure through anopening in the second protective enclosure. The method further comprisesadhering a cover to the second protective enclosure over the openingsuch that the cover cannot be separated from the second protectiveenclosure without damaging the second protective enclosure. The methodfurther comprises providing the electronic medical device containedwithin the second protective enclosure to a second user.

In an embodiment of the second aspect, the method further comprisescreating a disinfected field, wherein removing the electronic medicaldevice from the first protective enclosure and placing the electronicmedical device in a second protective enclosure are performed in thedisinfected field.

In an embodiment of the second aspect, removing the electronic medicaldevice from the first protective enclosure requires tearing the firstprotective enclosure.

In an embodiment of the second aspect, the method further comprisescleaning and disinfecting the electronic medical device.

In an embodiment of the second aspect, the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.

In a third aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the third aspect, certain ofthe present embodiments comprise a case for protecting an electronicmedical device. The case comprises a housing defining a cavityconfigured to receive an electronic medical device having a port. Thehousing comprises an opening located and configured to allow access tothe port when the electronic medical device is contained within thehousing. The housing further comprises a lock, which, when in a lockedposition, is configured to prevent opening of the housing to therebyselectively deter removal of the electronic medical device from thehousing.

In an embodiment of the third aspect, unlocking the lock enables removalof the electronic medical device from the housing.

An embodiment of the third aspect comprises the case in combination witha key configured to lock and unlock the lock.

In an embodiment of the third aspect, the housing comprises a firstportion and a second portion, and when the first and second portionsengage one another and the lock is in the locked position, the first andsecond portions cannot be separated from one another without damaging atleast one of the first and second portions.

In an embodiment of the third aspect, the housing, when in a closed andlocked configuration, meets the IPX7 standard with respect to waterpenetration.

In an embodiment of the third aspect, the housing comprises a materialselected from the group consisting of: polycarbonate and acrylonitrilebutadiene styrene (ABS).

In an embodiment of the third aspect, the electronic medical devicecomprises electronics and a display.

In an embodiment of the third aspect, the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.

In a fourth aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the fourth aspect, certain ofthe present embodiments comprise a case for protecting an electronicmedical device. The case comprises a housing defining a cavityconfigured to receive an electronic medical device having a port. Thehousing comprises a first portion, a second portion, and an openinglocated and configured to allow access to the port when the electronicmedical device is contained within the housing. The housing furthercomprises at least one fastener configured to secure the first andsecond portions to one another and prevent access to the cavity tothereby selectively deter removal of the electronic medical device fromthe housing. The fastener, when in a secured position, cannot be removedfrom the first and second portions by hand.

In a fifth aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the fifth aspect, certain ofthe present embodiments comprise a method for reprocessing a reusableelectronic medical device. The method comprises receiving an electronicmedical device from a first user, the electronic medical deviceincluding a water resistant protective coating. The method furthercomprises cleaning the electronic medical device to achieve aconcentration in protein on surfaces of the electronic medical device ofless than about 6.4 μg/cm², and a concentration in hemoglobin onsurfaces of the electronic medical device of less than about 2.2 μg/cm².The method further comprises disinfecting the electronic medical deviceto achieve reductions in duck hepatitis B virus of at least about a 3log₁₀ reduction, in klebsiella pneumonia of least about a 6 log₁₀reduction, in staphylococcus aureus of least about a 6 log₁₀ reduction,in escherichia coli of least about a 6 log₁₀ reduction, in pseudomonasaeruginosa of least about a 6 log₁₀ reduction, and in mycobacteriumterrae of least about a 3 log₁₀ reduction. At least one of cleaning theelectronic medical device or disinfecting the electronic medical devicecomprises submerging the electronic medical device in a cleaningsolution and/or a disinfecting solution. The method further comprisesproviding the cleaned and disinfected electronic medical device to asecond user.

In an embodiment of the fifth aspect, the water resistant protectivecoating protects the electronic medical device from damage from liquidingress.

In an embodiment of the fifth aspect, the method further comprisesdrying the electronic medical device.

In an embodiment of the fifth aspect, the electronic medical deviceincludes at least electronics, a port, a display, and a speaker.

In an embodiment of the fifth aspect, the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.

In a seventh aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the seventh aspect, certain ofthe present embodiments comprise a method for cleaning and disinfectingan electronic medical device. The method comprises cleaning theelectronic medical device to achieve a concentration in protein onsurfaces of the electronic medical device of less than about 6.4 μg/cm²,and a concentration in hemoglobin on surfaces of the electronic medicaldevice of less than about 2.2 μg/cm². The method further comprisesdisinfecting the electronic medical device to achieve reductions in duckhepatitis B virus of at least about 3 a log₁₀ reduction, in klebsiellapneumonia of at least about a 6 log₁₀ reduction, in staphylococcusaureus of at least about a 6 log₁₀ reduction, in escherichia coli of atleast about a 6 log₁₀ reduction, in pseudomonas aeruginosa of at leastabout a 6 log₁₀ reduction, and in mycobacterium terrae of at least abouta 3 log₁₀ reduction. The method further comprises drying the electronicmedical device.

In an embodiment of the seventh aspect, the electronic medical devicecomprises at least electronics, a port, a display, and a speaker.

In an embodiment of the seventh aspect, the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.

In an eighth aspect, which is generally applicable (i.e. independentlycombinable with any of the aspects or embodiments identified herein),particularly with any other embodiment of the eighth aspect, certain ofthe present embodiments comprise a kit for covering and protecting anelectronic medical device. The kit comprises a sleeve configured toreceive an electronic medical device having a port. The sleeve comprisesa first opening sized and configured to allow for insertion of theelectronic medical device into the sleeve and removal of the electronicmedical device from the sleeve. The sleeve further comprises a secondopening in the sleeve, the second opening being located so as to permitaccess to the port when the electronic medical device is received withinthe sleeve. The kit further comprises a first closure configured toadhere to a first portion of the sleeve and to overlie and seal thefirst opening. The kit further comprises a second closure configured toadhere to a second portion of the sleeve and to overlie and seal thesecond opening.

In an embodiment of the eighth aspect, the kit further comprises anacoustic spacer configured to be interposed between the sleeve and theelectronic medical device to create a space between the sleeve and theelectronic medical device.

In an embodiment of the eighth aspect, each of the first and secondclosures includes an adhesive backing.

In an embodiment of the eighth aspect, the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.

BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments now will be discussed in detail with an emphasison highlighting the advantageous features. These embodiments depict thenovel and non-obvious apparatus and methods for maintaining a medicaldevice in a clean and disinfected state, and for cleaning anddisinfecting a medical device, shown in the accompanying drawings, whichare for illustrative purposes only. These drawings include the followingfigures, in which like numerals indicate like parts:

FIG. 1 is a schematic view of a continuous analyte sensor systemattached to a host and communicating with other devices;

FIG. 2 is a rear perspective view of one embodiment of a protectivesleeve for receiving a medical device;

FIG. 3A is a front perspective view of the protective sleeve of FIG. 2with a medical device received therein;

FIG. 3B is a front perspective view of the protective sleeve and themedical device of FIG. 3A in combination with acoustic spacers;

FIG. 4A is a rear perspective view of the protective sleeve of FIG. 2;

FIG. 4B is a rear perspective view of another embodiment of a protectivesleeve for receiving a medical device;

FIG. 4C is perspective view of a kit including the protective sleeve ofFIG. 4B, one of the acoustic spacers of FIG. 3B, and closures configuredfor use with the sleeve of FIG. 4B;

FIG. 4D is a rear perspective view of the sleeve of FIG. 4B and theclosures of FIG. 4C;

FIG. 5 is a front perspective view of one embodiment of a case forreceiving a medical device;

FIG. 6 is a front perspective view of another embodiment of a case forreceiving a medical device; and

FIGS. 7 and 8 are flowcharts illustrating embodiments of methods forcleaning a medical device;

FIGS. 9 and 10 are flowcharts illustrating embodiments of methods fordisinfecting a medical device;

FIG. 11 is a flowchart illustrating another embodiment of a method forcleaning a medical device; and

FIG. 12 is a flowchart illustrating another embodiment of a method fordisinfecting a medical device.

DETAILED DESCRIPTION

The following detailed description describes the present embodimentswith reference to the drawings. In the drawings, reference numbers labelelements of the present embodiments. These reference numbers arereproduced below in connection with the discussion of the correspondingdrawing features.

The present embodiments are described below with reference to thefigures. These figures, and their written descriptions, may indicatethat certain components of the apparatus are formed integrally, andcertain other components are formed as separate pieces. Those ofordinary skill in the art will appreciate that components shown anddescribed herein as being formed integrally may in alternativeembodiments be formed as separate pieces. Those of ordinary skill in theart will further appreciate that components shown and described hereinas being formed as separate pieces may in alternative embodiments beformed integrally. Further, as used herein the term integral describes asingle unitary piece.

Sensor

The preferred embodiments relate to the use of an analyte sensor thatmeasures a concentration of glucose or a substance indicative of theconcentration or presence of the analyte. In some embodiments, theanalyte sensor is a continuous device, for example a subcutaneous,transdermal, transcutaneous, and/or intravascular (e.g., intravenous)device. In some embodiments, the device can analyze a plurality ofintermittent blood samples. The analyte sensor can use any method ofglucose-measurement, including enzymatic, chemical, physical,electrochemical, optical, optochemical, fluorescence-based,spectrophotometric, spectroscopic (e.g., optical absorptionspectroscopy, Raman spectroscopy, etc.), polarimetric, calorimetric,iontophoretic, radiometric, and the like.

The analyte sensor can use any known method, including invasive,minimally invasive, and non-invasive sensing techniques, to provide adata stream indicative of the concentration of the analyte in a host.The data stream is typically a raw data signal that is used to provide auseful value of the analyte to a user, such as a patient or health careprofessional (e.g., doctor), who may be using the sensor.

Although much of the description and examples are drawn to a glucosesensor, the systems and methods of the preferred embodiments can beapplied to any measurable analyte. In some preferred embodiments, theanalyte sensor is a glucose sensor capable of measuring theconcentration of glucose in a host. One example embodiment is describedbelow, which utilizes an implantable glucose sensor. However, it shouldbe understood that the devices and methods described herein can beapplied to any device capable of detecting a concentration of analyteand providing an output signal that represents the concentration of theanalyte.

In one preferred embodiment, the analyte sensor is an implantableglucose sensor, such as described with reference to U.S. Pat. No.6,001,067 and U.S. Patent Publication No. US-2011-0027127-A1. In anotherpreferred embodiment, the analyte sensor is a transcutaneous glucosesensor, such as described with reference to U.S. Patent Publication No.US-2006-0020187-A1. In yet another preferred embodiment, the analytesensor is a dual electrode analyte sensor, such as described withreference to U.S. Patent Publication No. US-2009-0137887-A1. In stillother embodiments, the sensor is configured to be implanted in a hostvessel or extracorporeally, such as is described in U.S. PatentPublication No. US-2007-0027385-A1.

Deposition Techniques

The membrane system can be deposited on the exposed electroactivesurfaces using any variety of known thin film techniques (for example,vapor deposition, spraying, printing (e.g., pad printing),electro-depositing, dipping, sputtering deposition, spin coating, powdercoating, and the like). In alternative embodiments, however, other vapordeposition processes (e.g., physical and/or chemical vapor depositionprocesses) can be useful for providing one or more of the insulatingand/or membrane layers, including ultrasonic vapor deposition,electrostatic deposition, evaporative deposition, deposition bysputtering, pulsed laser deposition, high velocity oxygen fueldeposition, thermal evaporator deposition, electron beam evaporatordeposition, deposition by reactive sputtering molecular beam epitaxy,atmospheric pressure chemical vapor deposition (CVD), atomic layer CVD,hot wire CVD, low-pressure CVD, microwave plasma-assisted CVD,plasma-enhanced CVD, rapid thermal CVD, remote plasma-enhanced CVD, andultra-high vacuum CVD, for example. However, the membrane system can bedisposed over (or deposited on) the electroactive surfaces using anyknown method, as will be appreciated by one skilled in the art.

Analyte List

The term “analyte” as used herein is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and it is not to be limited to a special or customized meaning),and refers without limitation to a substance or chemical constituent ina biological fluid (for example, blood, interstitial fluid, cerebralspinal fluid, lymph fluid or urine) that can be analyzed. Analytes mayinclude naturally occurring substances, artificial substances,metabolites, and/or reaction products. In some embodiments, the analytefor measurement by the sensor heads, devices, and methods disclosedherein is glucose. However, other analytes are contemplated as well,including but not limited to lactate or lactic acid; cardiac markers;ketone bodies; acetone; acetoacetic acid; beta hydroxybutyric acid;glucagon, acetyl Co A; intermediaries in the Citric Acid Cycle; choline,testosterone; creatinine; triglycerides; sodium; potassium; chloride;bicarbonate; total protein; alkaline phosphatase; calcium; phosphorus;PO₂; PCO₂; bilirubin (direct and total); red blood cell count; whiteblood cell count; hemoglobin; hemactocrit; lymphocytes; monocytes;eosinophils; basophils; c-reactive protein; cryoglobulins; fibrinogens;ACTH; aldosterone; ammonia; beta-HCG; magnesium; copper; iron; totalcholesterol; low density lipoproteins; high density lipoproteins;lipoprotein A; T4 (total and free); TSH; FSH; LH; ACTH; hepatitis BEantigen; hepatitis B surface antigen; hepatitis A antibody; hepatitis Cantibody; acarboxyprothrombin; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acidprofiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine,phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine;arabinitol enantiomers; arginase; benzoylecgonine (cocaine);biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4;ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol;cholinesterase; conjugated 1-B hydroxy-cholic acid; cortisol; creatinekinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine;de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylatorpolymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cysticfibrosis, Duchenne/Becker muscular dystrophy, analyte-6-phosphatedehydrogenase, hemoglobinopathies A, S, C, and E, D-Punjab,beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leberhereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexualdifferentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free B-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I; 17alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferrin;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids may also constitute analytes in certain embodiments. The analytemay be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte may be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbituates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body may also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC),homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and5-hydroxyindoleacetic acid (FHIAA).

High-Level CGM System Description

For illustrative purposes, reference will now be made to FIG. 1, whichis an example environment in which some embodiments described herein maybe implemented. Here, an analyte monitoring system 100 includes acontinuous analyte sensor system 8. Continuous analyte sensor system 8includes a sensor electronics module 12 and a continuous analyte sensor10. The system 100 can also include other devices and/or sensors, suchas a medicament delivery pump 2 and a reference analyte meter 4, asillustrated in FIG. 1. The continuous analyte sensor 10 may bephysically connected to sensor electronics module 12 and may be integralwith (e.g., non-releasably attached to) or releasably attachable to thecontinuous analyte sensor 10. Alternatively, the continuous analytesensor 10 may be physically separate to sensor electronics module 12,but electronically coupled via inductive coupling or the like. Further,the sensor electronics module 12, medicament delivery pump 2, and/oranalyte reference meter 4 may communicate with one or more additionaldevices, such as any or all of display devices 14, 16, 18, 20, and 21.

The system 100 of FIG. 1 also includes a cloud-based processor 22configured to analyze analyte data, medicament delivery data, and/orother patient related data provided over network 24 directly orindirectly from one or more of sensor system 8, medicament delivery pump2, reference analyte meter 4, and display devices 14-21. Based on thereceived data, the processor 22 can further process the data, generatereports providing statistic based on the processed data, triggernotifications to electronic devices associated with the host orcaretaker of the host, or provide processed information to any of theother devices of FIG. 1. In some example implementations, thecloud-based processor 22 comprises one or more servers. If thecloud-based processor 22 comprises multiple servers, the servers can beeither geographically local or separate from one another. The network 24can include any wired and wireless communication medium to transmitdata, including WiFi networks, cellular networks, the Internet and anycombinations thereof.

It should be understood that although the example implementationdescribed with respect to FIG. 1 refers to analyte data being receivedby processor 22, other types of data processed and raw data may bereceived as well.

In some example implementations, the sensor electronics module 12 mayinclude electronic circuitry associated with measuring and processingdata generated by the continuous analyte sensor 10. This generatedcontinuous analyte sensor data may also include algorithms, which can beused to process and calibrate the continuous analyte sensor data,although these algorithms may be provided in other ways as well. Thesensor electronics module 12 may include hardware, firmware, software,or a combination thereof to provide measurement of levels of the analytevia a continuous analyte sensor, such as a continuous glucose sensor.

The sensor electronics module 12 may, as noted, couple (e.g., wirelesslyand the like) with one or more devices, such as any or all of displaydevices 14, 16, 18, 20, and 21. The display devices 14, 16, 18, 20,and/or 21 may be configured for processing and presenting information,such sensor information transmitted by the sensor electronics module 12for display at the display device. The display devices 14, 16, 18, 20,and 21 can also trigger alarms based on the analyte sensor data.

In FIG. 1, display device 14 is a key fob-like display device, displaydevice 16 is a hand-held application-specific computing device 16 (e.g.the DexCom G4® Platinum receiver commercially available from DexCom,Inc.), display device 18 is a general purpose smart phone or tabletcomputing device 20 (e.g. an Apple® iPhone®, iPad®, or iPod touch®commercially available from Apple, Inc.), display device 20 is acomputer workstation 20, and display device 21 is any wearable. In someexample implementations, the relatively small, key fob-like displaydevice 14 may be a computing device embodied in a wrist watch, a belt, anecklace, a pendent, a piece of jewelry, an adhesive patch, a pager, akey fob, a plastic card (e.g., credit card), an identification (ID)card, and/or the like. This small display device 14 may include arelatively small display (e.g., smaller than the display device 18) andmay be configured to display a limited set of displayable sensorinformation, such as a numerical value 26 and/or an arrow 28. Incontrast, display devices 16, 18, and 20 can be larger display devicesthat can be capable of displaying a larger set of displayableinformation, such as a trend graph 30 depicted on the hand-held receiver16 in addition to other information such as a numerical value and arrow.

It is understood that any other user equipment (e.g. computing devices)configured to at least present information (e.g., a medicament deliveryinformation, discrete self-monitoring analyte readings, heart ratemonitor, caloric intake monitor, and the like) can be used in additionor instead of those discussed with reference to FIG. 1.

In some example implementations of FIG. 1, the continuous analyte sensor10 comprises a sensor for detecting and/or measuring analytes, and thecontinuous analyte sensor 10 may be configured to continuously detectand/or measure analytes as a non-invasive device, a subcutaneous device,a transdermal device, and/or an intravascular device. In some exampleimplementations, the continuous analyte sensor 10 may analyze aplurality of intermittent blood samples, although other analytes may beused as well.

In some example implementations of FIG. 1, the continuous analyte sensor10 may comprise a glucose sensor configured to measure glucose in theblood using one or more measurement techniques, such as enzymatic,chemical, physical, electrochemical, spectrophotometric, polarimetric,calorimetric, iontophoretic, radiometric, immunochemical, and the like.In implementations in which the continuous analyte sensor 10 includes aglucose sensor, the glucose sensor may be comprise any device capable ofmeasuring the concentration of glucose and may use a variety oftechniques to measure glucose including invasive, minimally invasive,and non-invasive sensing techniques (e.g., fluorescent monitoring), toprovide a data, such as a data stream, indicative of the concentrationof glucose in a host. The data stream may be raw data signal, which isconverted into a calibrated and/or filtered data stream used to providea value of glucose to a host, such as a user, a patient, or a caretaker(e.g., a parent, a relative, a guardian, a teacher, a doctor, a nurse,or any other individual that has an interest in the wellbeing of thehost). Moreover, the continuous analyte sensor 10 may be implanted as atleast one of the following types of sensors: an implantable glucosesensor, a transcutaneous glucose sensor, implanted in a host vessel orextracorporeally, a subcutaneous sensor, a refillable subcutaneoussensor, an intravascular sensor.

In some implementations of FIG. 1, the continuous analyte sensor system8 includes a DexCom G4® Platinum glucose sensor and transmittercommercially available from DexCom, Inc., for continuously monitoring ahost's glucose levels.

As discussed above, medical devices may in some cases be used by morethan one patient. For example, the medical device receiver 16 of FIG. 1may be used by multiple patients on a trial basis so that each patientcan determine whether a particular model of receiver is the right onefor him or her before committing to buying one. To reduce the spread ofdisease, it is desirable for such medical devices to be in a clean anddisinfected state when passed on to each patient. The presentembodiments, described in detail below, provide various apparatus andmethods for maintaining a medical device in a cleaned and disinfectedstate, and for cleaning and disinfecting a medical device after use.Protective Sleeve

FIGS. 2-4A illustrate one embodiment of a protective sleeve 200 forreceiving an electronic medical device 201 (FIG. 3A) to reduce the riskof contamination of the medical device 201. Under typical use, thesleeve 200 preferably resists penetration of contaminants into aninterior of the sleeve 200 so that such contaminants cannot reach themedical device 201 contained within the sleeve 200. In some embodiments,the sleeve 200 may be designed for a single use, after which the sleeve200 may be disposed of. In other embodiments, the sleeve 200 may bedesigned for multiple uses, which may comprise cleaning and disinfectingbetween uses.

With reference to FIG. 2, the sleeve 200 comprises a body portion 202defining an internal space 204 for receiving the medical device 201. Thebody portion 202 is sized and shaped such that it can be formed to havea shape such that the space 204 is substantially the same size and shapeas the medical device 201, so that the sleeve 200 fits over the medicaldevice 201 in a closely conforming fashion, as shown in FIGS. 3A and 3B.The body portion 202 may also be sized so that the space 204 is slightlysmaller than the medical device 201, so that the sleeve 200 stretches inorder to fit over the medical device 201 in a closely conformingfashion. In the illustrated embodiment, the sleeve 200 is shapedsubstantially as a rectangular parallelepiped when expanded, but inother embodiments the sleeve can be designed to have any shape to fitany of a variety of medical devices.

With reference to FIG. 4, a back panel 206 of the sleeve 200 includes aningress/egress opening 208 through which the medical device 201 may bepassed to insert the medical device 201 into the sleeve 200 and towithdraw the medical device 201 from the sleeve 200. In the illustratedembodiment, the opening 208 comprises a first slit 210 in the back panel206 that runs substantially parallel to a longitudinal axis of thesleeve 200, and a second slit 212 in the back panel 206 that runssubstantially perpendicular to the longitudinal axis of the sleeve 200,and which intersects a first end 214 of the first slit 210. The opening208 is thus substantially T-shaped. However, in other embodiments theopening 208 can have any of a variety of configurations.

With further reference to FIG. 4, an end panel 216 of the sleeve 200includes an access opening 218 through which one or more ports of themedical device 201 may be accessed. For example, the medical device 201may include a Universal Serial Bus (USB) port 220 (FIG. 3A) to enablethe medical device 201 to communicate with a computing system through awired connection, and/or a jack (not shown) for receiving a plug of acharging cord or adapter (not shown). The access opening 218 thusenables the medical device 201 to be charged and/or connected to acomputing system without the need to remove the sleeve 200.

The sleeve 200 is preferably constructed of a durable material (e.g., anelastic polymer) that can stretch and conform to the contours of themedical device 201. However, in some embodiments, the sleeve 200 may beformed of a rigid or semi-rigid material. In yet other embodiments, thesleeve may comprise one or more portions that comprise a rigid orsemi-rigid material and one or more other portions that comprise anelastic material. In some embodiments the sleeve 200 may be transparentor translucent, while in other embodiments the sleeve 200 may be opaque.For example, the sleeve 200 may comprise any of a variety of materials,including, but not limited to, polyurethane, polypropylene,polyethylene, polyethylene terephthalate, polyvinyl chloride,polyvinylidene chloride, polystyrene, polyamide, polycarbonate,silicone, neoprene, and copolymers or combinations thereof. The materialof the sleeve 200 is preferably resistant to common cleaning anddisinfecting solutions, such as, for example, water, an enzyme activepowdered detergent that is a concentrated anionic detergent, such asTERGAZYME®, bleach (e.g. up to 50% concentration), isopropyl alcohol(ISA), Pine Quat 64 Disinfectant (e.g. 100% concentration), 64 GeneralPurpose Disinfectant (e.g. 100% concentration), VirkonS (e.g. up to 10%concentration to warm water), Ali-Flex (e.g. 100% concentration), Windex(e.g. 100% concentration), Softsoap (e.g. approximately 2% concentrationto water), etc.

With further reference to FIG. 4, the back panel 206 of the sleeve 200comprises a first closure 222 adjacent the ingress/egress opening 208and a second closure 224 adjacent the access opening 218. Each of theillustrated closures 222, 224 is substantially rectangular, but in otherembodiments they could be any shape. The first closure 222 is configuredto selectively cover the ingress/egress opening 208, and the secondclosure 224 is configured to selectively cover the access opening 218,as described below.

The first closure 222 comprises a separate piece that is secured to theback panel 206 along a first edge 226, while the second closure 224comprises a separate piece that is secured to the end panel 216 along afirst edge 228. However, in alternative embodiments either or both ofthe closures 222, 224 may be integrally formed with the body 202.Dimensions of each closure 222, 224 are sufficient to enable eachclosure 222, 224 to completely cover its respective opening 208, 218.Adhesive(s) may be applied to either or both of the first and secondclosures 222, 224 and/or to either or both of the back panel 206 and theend panel 216. The adhesive(s) enable the closures 222, 224 to besecured to their respective panels 206, 216 while covering theirrespective openings 208, 218.

In one embodiment, a first adhesive 230 is applied to the first closure222 and/or to the back panel 206, and a second adhesive 232 is appliedto the second closure 224, and/or to the end panel 216, and/or to theback panel 206 adjacent the access opening 218, and the first and secondadhesives 230, 232 have different adhesion strengths. For example, thefirst adhesive 230 may have greater adhesion strength than the secondadhesive 232. In such an embodiment, the second closure 224 may berepeatedly adhered to and peeled from the back/end panel(s) 206, 216 sothat any ports covered by the second closure 224 can be repeatedlyaccessed and the access opening 218 subsequently resealed. But the firstadhesive 230 is preferably strong enough that the first closure 222,once sealed over the ingress/egress opening 208, cannot be peeled awayfrom the back panel 206 without tearing the first closure 222 and/or theback panel 206. This feature discourages the end user from trying toremove the medical device 201 from the sleeve 200, which could cause themedical device 201 to become soiled or contaminated. In someembodiments, each of the closures 222, 224 comprises an adhesive on theside that is to be adhered to the sleeve 200. A disposable peel-awaybacking paper (not shown) may cover the adhesive backing on each of theclosures 222, 224 to prevent the closures 222, 224 from adhering to anysurfaces prior to being secured to the sleeve 200, and to prevent theadhesive backings from attracting and adhering any debris prior to beingsecured to the sleeve 200.

The protective sleeve 200 described above allows the medical device 201to be used for multiple patients, with a new protective sleeve 200applied to the medical device 201 for each patient. The protectivesleeve 200 is disposable and is intended for single-patient use. Using anew protective sleeve 200 for each patient helps preventcross-contamination from patient to patient. The protective sleeve 200also protects the medical device 201 from contamination and liquidingress.

FIG. 3B illustrates the protective sleeve 200 and the medical device 201in combination with acoustic spacers 203. In the illustrated embodiment,the medical device 201 includes a pair of speakers 205 located atopposite corners 207 of one end of the medical device 201. The speakers205 are configured to emit audible tones, such as tones to alert thepatient to various conditions. The protective sleeve 200 overlies thespeakers 205. To reduce the attenuation of sound emanating from thespeakers 205, the acoustic spacers 203 may be interposed between themedical device 201 and the protective sleeve 200 at the corners 207, asfurther discussed below.

Each acoustic spacer 203 includes first and second segments 209, 211that extend in perpendicular directions from a junction 213. Eachacoustic spacer 203 is oriented such that the junction 213 aligns withits respective corner 207 of the medical device 201, with the first andsecond segments 209, 211 extending along perpendicular sides of themedical device 201, as shown in FIG. 3B. The acoustic spacers 203 createspacing between each of the speakers 205 and the protective sleeve 200,thereby reducing the extent to which the protective sleeve 200 mufflessound from the speakers 205.

In other embodiments, the acoustic spacer may have any of a variety ofshapes and dimensions that allow it to be interposed between the medicaldevice 201 and the protective sleeve 200. For example, in someembodiments the acoustic spacer may have any of a variety of shapes(e.g., oval, circle, rectangle, square, triangle, pentagon, hexagon,octagon, etc.) and dimensions that conform to a portion of the perimeter(or the entire perimeter) of a speaker.

In certain embodiments, the acoustic spacers 203 may be integral with ahousing of the medical device 201. In other embodiments, the acousticspacers 203 may be separate pieces that are securable to the housing ofthe medical device 201. For example, each of the acoustic spacers 203may include an adhesive backing to facilitate adhering the acousticspacers 203 to the medical device 201. The acoustic spacers 203 may bepart of a kit that also comprises the protective sleeve 200, asdescribed in further detail below with respect to the embodiment of FIG.4C. In yet other embodiments, the acoustic spacers may be integral withthe body 202 of the protective sleeve 200 and positioned at a locationthat allows them to be interposed between the medical device 201 and theprotective sleeve 200 at a region near one or more speakers.

FIG. 4B illustrates another embodiment of a protective sleeve 215 forreceiving a medical device. The sleeve of FIG. 4B is similar to theprotective sleeve 200 of FIGS. 2-4. Thus, common features will not bedescribed here. The sleeve 215 of FIG. 4B includes an access opening 217in an end panel 219 of the protective sleeve 215. The access opening 217is sized and located so as to provide access to a port of the medicaldevice (not shown), such as a USB port.

FIG. 4C illustrates a kit 221 including the protective sleeve 215 ofFIG. 4B, one of the acoustic spacers 203 of FIG. 3B, and closures 223,225 configured to overlie and seal the ingress/egress opening 208 andthe access opening 217. A first one of the closures 223 is shaped as atriangle, and is configured to overlie and seal the ingress/egressopening 208, as shown in FIG. 4D. A second one of the closures 225 isshaped as a rectangle (e.g., a square), and is configured to overlie andseal the access opening 217, as also shown in FIG. 4D. Each of theclosures 223, 225 may include an adhesive backing so that the closures223, 225 adhere to the sleeve 215 and seal the openings 208, 217. Adisposable peel-away backing paper (not shown) may cover the adhesivebacking on each of closures 223, 225 to prevent the closures 223, 225from adhering to any surfaces prior to being secured to the sleeve 215,and to prevent the adhesive backings from attracting and adhering anydebris prior to being secured to the sleeve 215.

The closures 223, 225 may be single-use, such that once a closure 223,225 is adhered to the sleeve 215 and later removed from the sleeve 215,it is not reused thereafter. In such embodiments, one suitable materialfor the closures 223, 225 is FasCal® 400 series multi-purposescreenprint film including a removable, acrylic-based adhesive,available from Avery Dennison. In such embodiments, the adhesive may bethe same for each of the closures 223, 225. In other embodiments, theclosures 223, 225 may comprise an adhesive backing that allows theclosures to be peeled off from and re-adhered to the sleeve 215 multipletimes.

Protective Cases

FIGS. 5 and 6 illustrate embodiments of protective cases 500, 600 forreceiving a medical device 502, 602 to reduce the risk of contaminationof the medical device 502, 602. The case 500, 600 preferably resistspenetration of contaminants into an interior of the case 500, 600 sothat such contaminants cannot reach the medical device 502, 602contained within the case 500, 600. Each case 500, 600 further includesa mechanism that at least discourages, if not prevents, the end userfrom opening the case 500, 600, which would expose the medical device502, 602 to contaminants.

With reference to FIG. 5, one embodiment comprises a case 500 having afront portion 504 and a back portion 506. The front and back portions504, 506 are securable to one another with the medical device 502contained within an interior space defined by the mated front and backportions 504, 506. A gasket 508 may be received about a periphery of thejunction of the front and back portions 504, 506 to resist moisturepenetration into the interior space of the case 500. The gasket 508 maybe of a resilient, moisture resistant material, such as silicone, latex,rubber, and the like.

The front portion 504 of the case 500 of FIG. 5 includes a transparentor translucent window 510 through which a display 512 of the medicaldevice 502 is visible. The window 510 is received within a frame 514defined by an opening in the front portion 504. Edges of the window 510are preferably secured to the frame 514 in a moisture-tight fashion toresist moisture penetration into the interior space of the case 500. Thewindow 510 may be constructed from any suitable material that is durableand transparent or translucent, such as, for example, plastic,polycarbonate, and the like. As illustrated in FIG. 5, the window 510 ispreferably recessed beneath a front surface 516 of the case 500 in orderto make it less likely that the window 510 will get scratched.

The front portion 504 of the case 500 of FIG. 5 further includes a touchpad 518. The location of the touch pad 518 corresponds to the locationof a touch pad (not visible in FIG. 5, but located behind the touch pad518) on the medical device 502. The user can manipulate the touch pad518 on the case 500 by pressing on any area of it with his or herfinger(s) and/or thumb(s), and the digital pressure applied istransmitted to the touch pad on the medical device 502 to thereby enablethe user to control the operation of the medical device 502. Forexample, in some embodiments the touch pad 518 on the case 500 may beconstructed of a flexible and resilient material, such as, for example,silicone, latex, rubber, and the like. In other embodiments the touchpad 518 on the case 500 may be constructed of a rigid or semi-rigidmaterial, such as, for example, plastic, polycarbonate, and the like.

Edges of the touch pad 518 on the case 500 are preferably secured to thecase 500 in a moisture-tight fashion to resist moisture penetration intothe interior space of the case 500. The case 500 of FIG. 5 preferablyincludes one or more openings or ports (not shown) that enable the userto access any ports on the medical device 502. For example, the medicaldevice 502 may include a Universal Serial Bus (USB) port to enable themedical device 502 to communicate with a computing system through awired connection, and/or a jack for receiving a plug of a charging cordor adapter.

The front and back portions 504, 506 of the case 500 further include alocking mechanism that deters the user from opening the case 500. Forexample, in the illustrated embodiment, a lock 520 is located in anupper right-hand corner of the front and back portions 504, 506, andoverlaps the junction of front and back portions 504, 506. When in alocked position, the lock 520 prevents the case 500 from being opened.Preferably, the patient is not provided with a key to unlock the lock520, so that the patient is discouraged from trying to open the case500, which could cause the medical device 502 inside to becomecontaminated. Another person, such as a physician who provides themedical device 502 to the patient, preferably possesses the key so thatwhen the patient returns the medical device 502 to the physician at theend of a trial period the physician can open the case 500 and remove themedical device 502 from the case 500 for cleaning and disinfecting.

The structure of the lock 520 may vary in complexity. For example, insome embodiments the lock 520 may comprise something as simple as aremovable threaded member (e.g. a bolt, a screw, and the like). In suchembodiments, the lock 520 may be “opened” with a tool (e.g. ascrewdriver, an Allen key, and the like) that mates with the head of thethreaded member. In other embodiments, the lock 520 may be more complex,such as one requiring a key to open (e.g. a warded lock, a pin tumblerlock, a wafer tumbler lock, a disc tumbler lock or Abloy lock, a levertumbler lock, and the like). In still other embodiments, the lock 520may comprise a combination lock, a time lock, or any other type of lock.

FIG. 6 illustrates another embodiment of a protective case 600 forreceiving a medical device 602 to reduce the risk of contamination ofthe medical device 602. Like the embodiment of FIG. 5, the case 600 ofFIG. 6 includes a front portion 604 and a back portion 606, a gasket 608around the junction of the front and back portions 604, 606, a window610 through which the display 612 of the medical device 602 is visible,and a touch pad 614. An end of the case 600 includes a port 616 throughwhich the user may insert a plug of a USB cable. Other ports (not shown)may also be provided for connecting other cables/devices, such as apower cord. Although not shown in the drawings, in some embodiments, thecase 600 includes a separate plug that is shaped and sized to fit theport 616 and that may be used to provide the medical device 602 with aliquid tight seal when the port 616 is not in use. By establishing aliquid-tight seal through the use of the plug, the case 600 can becleaned and/or disinfected many times without exposing the medicaldevice 602 to cleaning or disinfecting solutions. Although not shown inthe drawings, in other embodiments the case 600 comprises a flap that isintegrally formed with the body of the case. The flap may be configuredto have an unlocked and a locked position. When in the unlockedposition, the flap may be opened to allow access to the port 616.Conversely, when in the locked positioned, the flap is closed andprovides the medical device 600 with a liquid tight seal. In still otherembodiments, closures comprising adhesives may be used to seal off theport 616 when it is not in use.

Each corner of the case 600 includes a threaded opening 618 forreceiving a fastening member, such as a screw 620. The screws 620 arereceived in the threaded openings 618 that extend through the frontportion 604 and at least partially through the back portion 606 tosecure the front and back portions 604, 606 to one another. In someembodiments, the opening through the front portion 604 may not bethreaded. Also, other fastening members, such as may be used instead ofthe screws 620.

The screws 620 provide a deterrent that discourages the patient fromopening the case 600. A head of each screw 620 may include a standardfeature that can be engaged by one or more common tools, such as a hexkey or a screwdriver (flathead or Phillips-head). Alternatively, thehead of each screw 620 may be configured such that it will only matewith a special tool that may not be readily available to the patient. Ineither case, the presence of the screws 620 provides a visual reminderto the patient that it is undesirable for him or her to open the case600, thereby helping to prevent contamination of the medical device 602.

The illustrated shapes and configurations of the cases 500, 600 of FIGS.5 and 6 are merely examples that are tailored to receive medical devices502, 602 having the illustrated shapes, configurations, features, etc.For other medical devices having different shapes, configurations,features, etc., a given case according to the present embodiments wouldbe shaped and configured differently than as illustrated in FIGS. 5 and6 in order to accommodate such other medical devices. Such changes inshape, configuration, etc. are within the scope of the presentembodiments.

As discussed above, the cases 500, 600 described above with reference toFIGS. 5 and 6 restrict access to the medical device. They also cover themedical device and allow the exterior of the case to be cleaned anddisinfected without damaging the functionality of the medical device.Once attached to the medical device, the case makes the unit waterresistant and resistant to common cleaning and disinfection solutionsand brushes. Without the case, the unit may be prone to electronicsdamage from liquid ingress. Further, without the case, the medicaldevice may be prone to being scratched, dented, cracked, etc.

In some embodiments, the protective cases 500, 600 described above areresistant to common cleaning and disinfecting solutions, such as, forexample, water, TERGAZYME®, bleach (e.g. up to 50% concentration),isopropyl alcohol, (ISA), etc. The protective cases are preferably madeof a durable, impact-resistant plastic, and fit to the contours of themedical device. Once attached to the medical device, the cases cannot beeasily removed without a tool. This feature makes the cases asemi-permanent attachment to the medical device and deters the user fromremoving the medical device from the cases. The protective cases haveone or more access ports that allow the user to easily access any portson the medical device. Any ports in the cases are preferably closable orcoverable to enhance the water resistance of the cases. The protectivecases may be used multiple times by multiple patients. The cases arepreferably cleaned and disinfected between patients.

The protective cases 500, 600 described above are preferably designed tobe effectively cleaned and disinfected. The following features allow thecases to be effectively cleaned and disinfected: As few grooves aspossible, any grooves present are large enough to clean with wipes, asfew nooks and crannies as possible, an optional antimicrobial coating,water resistance so that it can be submerged in common cleaning anddisinfection solutions, resistant to cleaning brushes, able to becleaned with moistened wipes (i.e. no brush required), and able towithstand 100 wipes with 10% bleach solution and 100 wipes with 70%isopropyl alcohol.

The protective cases 500, 600 described above preferably provide thefollowing characteristics: Ingress Protection Rating of IPX6 or greater,full device functionality inside case (e.g. does not attenuate soundsubstantially, maintains access to charge port, no impact on RFperformance, no impact on IEC 60601 certification of the medical device,etc.), scratch resistance, fog resistance, reduced bulkiness, little tono impact on shipping configuration/validation, and semi-permanentattachment (e.g. can only be removed with a special tool).

The protective cases described above allow the medical device to be usedfor multiple patients. The protective case is preferably durable so thatit may be used multiple times by multiple patients, preferably beingcleaned and disinfected between patients. The protective cases alsopreferably protect the medical device from liquid ingress, andpreferably protect the medical device from common cleaning anddisinfecting solutions. The protective cases also prevent the medicaldevice from getting scratched or damaged during normal use.

While the description above refers to a receiver of a CGM system(illustrated in FIG. 3A), the present embodiments are not limited to areceiver. The present embodiments are equally adaptable for use with anymedical device, such as, for example, a transmitter of a CGM system, anyother component of an analyte monitoring system, or any other medicaldevice.

Cleaning and Disinfecting Methods

Certain of the present embodiments comprise methods for cleaning anddisinfecting a medical device. Generally, cleaning the device involvesremoving soil from the device and preparing the device for disinfection.In certain embodiments, cleaning the medical device reduces proteinconcentration on surfaces of the medical device to less than about 6.4μg/cm², and reduces hemoglobin concentration on surfaces of the medicaldevice to less than about 2.2 μg/cm². Disinfection involves inactivatingmicrobial organisms and/or viruses on the device, rendering the devicesafe for use by another patient. In certain embodiments, disinfectingthe medical device achieves the following reductions in theconcentration of various microbes on surfaces of the electronic device,as compared to a pre-disinfected state: duck hepatitis B virus greaterthan about 3 log₁₀ reduction, klebsiella pneumonia greater than about 6log₁₀ reduction, staphylococcus aureus greater than about 6 log₁₀reduction, escherichia coli greater than about 6 log₁₀ reduction,pseudomonas aeruginosa greater than about 6 log₁₀ reduction, andmycobacterium terrae greater than about 3 log₁₀ reduction.

With reference to FIG. 7, one method for cleaning a medical devicecomprises the following steps. In box B700, an operator prepares acleaning solution by mixing a detergent with potable tap water. Forexample, the detergent may comprise an enzymatic detergent containingone or more of sodium bicarbonate, sodium tripolyphosphate, sodiumcarbonate, sodium alkybenzene sulfonate, and other non-hazardousingredients of less than 1% concentration. For example, the detergentmay comprise TERGAZYME®, and the cleaning solution may comprise a 1%TERGAZYME® solution. The 1% TERGAZYME® solution may be produced by, forexample, mixing 1¼ TBSP TERGAZYME® with ½ gallon of potable tap water.

In box B702, the operator applies clean gloves to his or her hands. Thegloves are preferably resistant to chemicals that may be used in thecleaning method. In box B704, if the medical device includes any ports,such as a charging port, a USB (Universal Serial Bus) port, etc., theoperator ensures that such ports are covered. For example, the medicaldevice may include a cover for each port, such as a sliding or swingingdoor. If the medical device does not include a cover or covers, theoperator may cover each port with a temporary, single-use, disposableport cover, which is used to protect the medical device during cleaningand disinfection (e.g. a custom or off-the-shelf plug, tape, and thelike).

In box B706, the operator moistens a clean, dry wipe or cloth with thecleaning solution and squeezes out any excess liquid. Preferably, thewipe or cloth is also low lint. For example, the wipe or cloth maycomprise a microfiber wipe or cloth. In box B708, the operator wipes allsurfaces of the medical device with the moistened wipe or cloth to applycleaning solution to all surfaces. In one embodiment, a method of wipingthe medical device may comprise the following steps, in no particularorder: folding the wipe into quarters; with a first surface of the wipe,wiping the top of the medical device; refolding the wipe to expose aclean second surface; with the clean second surface wiping all sides ofthe medical device, refolding the wipe again to expose a clean thirdsurface; and, with the clean third side of the wipe, wiping the bottomof the medical device.

In box B710, the operator dips a brush into the cleaning solution andtaps or shakes off any excess liquid. In certain embodiments, thebristles of the brush may be a soft material (e.g. nylon and the like)that will not scratch or haze the surfaces of the medical device. In boxB712, the operator scrubs all surfaces of the medical device using thebrush. In one embodiment, the operator may scrub the medical device fora minimum duration, such as 15 seconds, 30 seconds, 45 seconds, 60seconds, etc. Preferably, the operator thoroughly scrubs areas wheresoil may collect, such as seams and crevices, e.g. around any buttonsand/or ports.

In box B714, the operator repeats boxes B706 and B708. In box B716, theoperator applies a new pair of clean gloves to his or her hands. In boxB720, the operator moistens a new clean, dry wipe or cloth with potabletap water and squeezes out any excess liquid. The operator then wipesall surfaces of the medical device with the moistened wipe. In oneembodiment, a method of wiping the medical device may comprise the samesteps outlined above with respect to box B708. In box B722, the operatordries the medical device by wiping with a clean, dry wipe or cloth,which is also preferably low-lint. The operator may refold the wipe toexpose a dry surface as needed. In box B724, the operator allows themedical device to dry. In certain embodiments, the medical device may beinverted (keypad and screen facing down) for drying, and any portsthereon may remain open. In one embodiment, the operator may allow themedical device to dry for a minimum duration, such as 30 minutes, 45minutes, 60 minutes, etc.

With reference to FIG. 8, another method for cleaning a medical devicecomprises the following steps. In box B800, the operator prepares acleaning solution. In certain embodiments, the cleaning solution may beprepared according to the ratios/methods described above with respect tobox B700. In box B802, the operator applies a pair of clean gloves tohis or her hands. In box B804, if the medical device includes any ports,such as a charging port, a USB (Universal Serial Bus) port, etc., theoperator ensures that such ports are covered, similar to box B704described above. In box B806, the operator submerges the medical devicein the cleaning solution and scrubs all surfaces using a brush while themedical device is submerged. The brush and duration of scrubbing may besimilar to those described above with respect to boxes B710 and B712.After brushing, the operator leaves the medical device submerged to soakin the cleaning solution for a minimum duration, such as 30 seconds, 45seconds, 60 seconds, 90 seconds, 2 minutes, etc. In one embodiment, thetotal duration for which the medical device remains submerged, includingscrubbing and soaking, is 3 minutes. In box B808, the operator applies anew pair of clean gloves to his or her hands. In box B810, the operatorremoves the medical device from the cleaning solution and rinses underrunning, potable tap water for a minimum duration, such as 5 seconds, 10seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, etc. In boxB812, the operator dries the medical device by wiping with a clean, drywipe or cloth, which is also preferably low-lint. The operator mayrefold the wipe to expose a dry surface as needed.

Generally, disinfecting the device involves inactivating bacteria,fungi, and/or viruses that may be resident on the medical device. Incertain embodiments, the disinfecting methods include a disinfectingsolution, which may be, for example, an off-the-shelf spray preparation,which may contain bleach. One such disinfecting solution may beDispatch® Hospital Cleaner Disinfectant with Bleach, whichadvantageously has a short contact time and provides for ease of use. Incertain embodiments, the disinfecting solution may be contained in aneasy-to-use spray bottle.

With reference to FIG. 9, one method for disinfecting a medical devicecomprises the following steps. In box B900, the operator applies a pairof clean gloves to his or her hands. In box B902, if the medical deviceincludes any ports, such as a charging port, a USB (Universal SerialBus) port, etc., the operator ensures that such ports are covered,similar to box B704 described above. In box B904, the operator placesthe medical device screen side (front side) up on a clean, flat surface.In box B906, the operator holds the disinfecting solution spray bottleproximate the medical device front surface. For example, in oneembodiment the operator may hold the spray bottle 6″-8″ from the medicaldevice front surface. In box B908, the operator sprays the disinfectingsolution onto the medical device front surface until thoroughly wetted.The operator may tilt the medical device if necessary to ensure thedisinfecting solution has covered the entire front surface. In box B910,the operator turns the medical device over so that the back surface isfacing up. In box B912, the operator wets the medical device backsurface with the disinfecting solution in the same manner as in boxesB906 and B908.

In box B914, the operator wets each side (or edge) of the medical devicewith the disinfecting solution in the same manner as in boxes B906 andB908. However, in certain embodiments, the operator does not wet (or atleast does not directly spray) any side of the medical device thatincludes at least one port. In box B916, the operator allows the medicaldevice to sit wetted for a minimum duration, such as 30 seconds, 45seconds, 60 seconds, 90 seconds, 2 minutes, 5 minutes, etc.

In box B918, the operator wets an absorbent wipe with a seconddisinfecting solution, such as a 70% isopropyl alcohol (IPA) solution.In box B920, the operator wipes down all outside surfaces of the medicaldevice to remove any residue, such as bleach residue. In box B922, theoperator uncovers any ports that were covered in box B902 and wipes ordabs any liquid residue from interior surfaces of the port(s).Preferably, the operator avoids contacting any metal components of theport(s) with the second disinfecting solution so as to avoid causing anelectrical short.

In box B924, the operator wipes the exterior of the medical devicecompletely dry with an absorbent wipe, and dries around any ports withan absorbent wipe if any liquid is observed. In box B926, the operatorallows the medical device to dry in the same manner as described withrespect to box B724.

With reference to FIG. 10, another method for disinfecting a medicaldevice comprises the following steps. In box B1000, the operator appliesa pair of clean gloves to his or her hands. In box B1002, the operatorplaces the medical device on a flat surface such that any electricalcontacts thereon face the flat surface. In boxes B1004 and B1006, theoperator wets the medical device front surface with the disinfectingsolution in a similar manner as described above with respect to boxesB906 and B908. In box B1008, the operator turns the medical device overso that the electrical contacts face up. In box B1010, the operator wetsthe medical device back surface with the disinfecting solution in thesame manner as in boxes B1004 and B1006.

In box B1012, the operator allows the medical device to sit wetted for aminimum duration, such as 30 seconds, 45 seconds, 60 seconds, 90seconds, 2 minutes, 5 minutes, etc. In box B1014, the operator wipes themedical device completely dry with an absorbent wipe. In box B1016, theoperator wets an absorbent wipe with a second disinfecting solution,such as a 70% isopropyl alcohol (IPA) solution. In box B1018, theoperator wipes down all outside surfaces of the medical device to removeany residue, such as bleach residue. In box B1020, the operator allowsthe medical device to dry in the same manner as described with respectto box B724.

With reference to FIG. 11, another method for cleaning a medical devicecomprises the following steps. In box B1100, the operator applies a pairof clean gloves to his or her hands. In box B1102, the operator preparesa soaking solution by adding enough bleach solution to a container tosubmerge the medical device. In box B1104, the operator places themedical device on a flat surface such that any electrical contactsthereon face the flat surface. In boxes B1106 and B1108, the operatorwets the medical device front surface with the disinfecting solution ina similar manner as described above with respect to boxes B906 and B908.In box B1110, the operator turns the medical device over so that theelectrical contacts face up. In box B1112, the operator wets the medicaldevice back surface with the disinfecting solution in the same manner asin boxes B1104 and B1106.

In box B1114, the operator scrubs all surfaces of the medical deviceusing a brush for a minimum duration. In box B1116, the operatorsubmerges the medical device in the cleaning solution for a minimumduration. In box B1118, the operator removes the medical device from thecleaning solution and rinses it under tap water for a minimum duration.In box B1120, the operator wipes the medical device completely dry.

With reference to FIG. 12, another method for disinfecting a medicaldevice comprises the following steps. In box B1200, the operator appliesa pair of clean gloves to his or her hands and goggles over his or hereyes. In box B1202, the operator prepares a soaking solution by addingenough bleach solution to a container to submerge the medical device. Inbox B1204, the operator removes a pre-saturated disinfectant (e.g.bleach) wipe from its packaging. In box B1206, the operator folds thewipe into a 2″×2″ square. In box B1208, the operator wipes all surfacesof the medical device by passing over the medical device surface in onedirection and then back in the opposite direction (back and forth, twopasses). In box B1210, the operator turns over the wipe to use a cleanside for a second back and forth wipe. In box B1212, the operatorrefolds the wipe to use a clean side for a third back and forth wipe. Inbox B1214, the operator turns over the wipe to use a clean side for afourth back and forth wipe for a total of eight passes, ensuring thatall medical device surfaces are covered with disinfectant (e.g. bleach).

In box B1216, the operator places the medical device on a clean,non-porous surface and allows the disinfectant to contact the medicaldevice for a minimum duration. In box B1218, the operator places themedical device in the soaking solution for a minimum duration. In boxB1220, the operator removes the medical device from the soaking solutionand rinses it under flowing tap water for a minimum duration. In boxB1222, the operator wipes the medical device with a cloth until it iscompletely dry.

In a further embodiment, an electronic medical device, such as theelectronic medical device 201 shown in FIG. 3A, may include a coating ofa liquid repellant (e.g., hydrophobic) substance. The coating maysurround all exposed electrical surfaces of the electronic medicaldevice and seal any cracks, fissures, etc. The coating may be invisibleto the human eye. For example, one suitable coating is available fromLiquipel of Santa Ana, Calif. In one study, tests were conductedcomparing the effectiveness of the above-described coating in allowing amedical device to be cleaned and in a variety of cleaning solutionswithout sustaining damage. In this study, five DexCom G4® Platinumreceivers comprising the test group were coated with Liquipel. Anotherfive DexCom G4® Platinum receivers comprising the control group were notcoated with Liquipel. The study comprised 10 cleaning cycles, in whicheach cleaning cycle comprised the following steps: (1) wiping thereceiver with a detergent; (2) brushing the receiver while exposed tothe detergent; (3) wiping the receiver with the detergent; (4) wipingthe receiver with water; (5) wiping dry the receiver; (6) setting thereceiver for five minutes; (7) spraying the receiver with bleach; (8)setting the receiver for five minutes; (9) wiping dry the receiver; (10)wiping the receiver with alcohol; (11) wiping dry the receiver; (12)setting the receiver for one hour. With the test group, all fivereceivers underwent the 10 cleaning cycles without suffering anyfailures. With the control, however, only one of the four receivers didnot suffer failure after the 10 cleaning cycles. Of the five receiversin the control group, two suffered USB failure by the fourth cleaningcycle, one suffered USB failure by the eighth cleaning cycle, and onesuffered an unintended reset (i.e., stuck in manufacturing mode) by thesecond cleaning cycle. The study clearly demonstrated the viability ofcoating a medical device with a liquid repellant substance (e.g.,Liquipel) to transform It into a device that can be exposed to commonagents, such bleach, and/or water, without sustaining damage.

As expected, positive control receivers exhibited failures due to liquidingress.

a. 80% failure rate after 10 cycles of cleaning and disinfection.

As expected, negative control receivers continued to function properlydue to no liquid exposure.

a. 0% failure rate.

Liquipel was effective at protecting the receiver from damage due toliquid ingress.

-   -   a. All Liquipel receivers continued to function properly after        10 cycles of cleaning and disinfection.    -   b. 0% failure rate after 10 cycles of cleaning and disinfection        In an example process cif applying the coating to the electronic        medical device, the placed in an airtight chamber from which        substantially all air is evacuated to create a vacuum. Once the        vacuum has been established, the coating material may be        injectedinto the chamber in liquid form. Upon entering the        vacuum chamber, the liquid becomes a gas. Plasma is then        introduced into the vacuum chamber. The plasma decomposes the        liquid repellant molecules, polymerizing them to themselved. Air        is then reintroduced into the chamber until it returns to        atmospheric pressure. The electronic medical device is then        removed from the chamber and the process is complete.

The above description presents the best mode contemplated for carryingout the present invention, and of the manner and process of practicingit, in such full, clear, concise, and exact terms as to enable anyperson skilled in the art to which they pertain to practice thisinvention. This invention is, however, susceptible to modifications andalternate constructions from those discussed above that are fullyequivalent. Consequently, this invention is not limited to theparticular embodiments disclosed. On the contrary, this invention coversall modifications and alternate constructions coming within the spiritand scope of the invention as generally expressed by the followingclaims, which particularly point out and distinctly claim the subjectmatter of the invention.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not by way of limitation. Likewise, the various diagrams maydepict an example architectural or other configuration for thedisclosure, which is done to aid in understanding the features andfunctionality that can be included in the disclosure. The disclosure isnot restricted to the illustrated example architectures orconfigurations, but can be implemented using a variety of alternativearchitectures and configurations. Additionally, although the disclosureis described above in terms of various exemplary embodiments andimplementations, it should be understood that the various features andfunctionality described in one or more of the individual embodiments arenot limited in their applicability to the particular embodiment withwhich they are described. They instead can be applied, alone or in somecombination, to one or more of the other embodiments of the disclosure,whether or not such embodiments are described, and whether or not suchfeatures are presented as being a part of a described embodiment. Thusthe breadth and scope of the present disclosure should not be limited byany of the above-described exemplary embodiments.

It will be appreciated that, for clarity purposes, the above descriptionhas described embodiments with reference to different functional units.However, it will be apparent that any suitable distribution offunctionality between different functional units may be used withoutdetracting from the invention. For example, functionality illustrated tobe performed by separate computing devices may be performed by the samecomputing device. Likewise, functionality illustrated to be performed bya single computing device may be distributed amongst several computingdevices. Hence, references to specific functional units are only to beseen as references to suitable means for providing the describedfunctionality, rather than indicative of a strict logical or physicalstructure or organization.

Embodiments of the present disclosure are described above and below withreference to flowchart illustrations of methods, apparatus, and computerprogram products. It will be understood that each block of the flowchartillustrations, and combinations of blocks in the flowchartillustrations, can be implemented by execution of computer programinstructions. These computer program instructions may be loaded onto acomputer or other programmable data processing apparatus (such as acontroller, microcontroller, microprocessor or the like) in a sensorelectronics system to produce a machine, such that the instructionswhich execute on the computer or other programmable data processingapparatus create instructions for implementing the functions specifiedin the flowchart block or blocks. These computer program instructionsmay also be stored in a computer-readable memory that can direct acomputer or other programmable data processing apparatus to function ina particular manner, such that the instructions stored in thecomputer-readable memory produce an article of manufacture includinginstructions which implement the function specified in the flowchartblock or blocks. The computer program instructions may also be loadedonto a computer or other programmable data processing apparatus to causea series of operational steps to be performed on the computer or otherprogrammable apparatus to produce a computer implemented process suchthat the instructions which execute on the computer or otherprogrammable apparatus provide steps for implementing the functionsspecified in the flowchart block or blocks presented herein.

It should be appreciated that all methods and processes disclosed hereinmay be used in any glucose monitoring system, continuous orintermittent. It should further be appreciated that the implementationand/or execution of all methods and processes may be performed by anysuitable devices or systems, whether local or remote. Further, anycombination of devices or systems may be used to implement the presentmethods and processes.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive. Thedisclosure is not limited to the disclosed embodiments. Variations tothe disclosed embodiments can be understood and effected by thoseskilled in the art in practicing the claimed disclosure, from a study ofthe drawings, the disclosure and the appended claims.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein. It should benoted that the use of particular terminology when describing certainfeatures or aspects of the disclosure should not be taken to imply thatthe terminology is being re-defined herein to be restricted to includeany specific characteristics of the features or aspects of thedisclosure with which that terminology is associated. Terms and phrasesused in this application, and variations thereof, especially in theappended claims, unless otherwise expressly stated, should be construedas open ended as opposed to limiting. As examples of the foregoing, theterm ‘including’ should be read to mean ‘including, without limitation,’including but not limited to,' or the like; the term ‘comprising’ asused herein is synonymous with ‘including,’ containing,' or‘characterized by,’ and is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps; the term ‘having’ shouldbe interpreted as ‘having at least;’ the term ‘includes’ should beinterpreted as ‘includes but is not limited to;’ the term ‘example’ isused to provide exemplary instances of the item in discussion, not anexhaustive or limiting list thereof; adjectives such as ‘known’,‘normal’, ‘standard’, and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass known, normal, or standard technologies that may be availableor known now or at any time in the future; and use of terms like‘preferably,’ preferred,‘desired,’ or ‘desirable,’ and words of similarmeaning should not be understood as implying that certain features arecritical, essential, or even important to the structure or function ofthe invention, but instead as merely intended to highlight alternativeor additional features that may or may not be utilized in a particularembodiment of the invention. Likewise, a group of items linked with theconjunction ‘and’ should not be read as requiring that each and everyone of those items be present in the grouping, but rather should be readas ‘and/or’ unless expressly stated otherwise. Similarly, a group ofitems linked with the conjunction ‘or’ should not be read as requiringmutual exclusivity among that group, but rather should be read as‘and/or’ unless expressly stated otherwise.

Where a range of values is provided, it is understood that the upper andlower limit, and each intervening value between the upper and lowerlimit of the range is encompassed within the embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity. The indefinite article “a” or “an” does not exclude aplurality. A single processor or other unit may fulfill the functions ofseveral items recited in the claims. The mere fact that certain measuresare recited in mutually different dependent claims does not indicatethat a combination of these measures cannot be used to advantage. Anyreference signs in the claims should not be construed as limiting thescope.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

What is claimed is:
 1. An enclosure for an electronic medical device,the enclosure comprising: a sleeve configured to receive an electronicmedical device having a port; a first opening in the sleeve sized andconfigured to allow for insertion of the electronic medical device intothe sleeve and removal of the electronic medical device from the sleeve;a second opening in the sleeve, the second opening being located so asto permit access to the port when the electronic medical device isreceived within the sleeve; a first cover configured to adhere to afirst portion of the sleeve and to cover the first opening; and a secondcover configured to adhere to a second portion of the sleeve and tocover the second opening.
 2. The enclosure of claim 1, furthercomprising a first adhesive located and configured to secure the firstcover to the sleeve at the first portion.
 3. The enclosure of claim 2,further comprising a second adhesive located and configured to securethe second cover to the sleeve at the second portion.
 4. The enclosureof claim 3, wherein the first adhesive comprises a first peel strength,the second adhesive comprises a second peel strength, and the first peelstrength is different than the second peel strength.
 5. The enclosure ofclaim 4, wherein the first peel strength is greater than the second peelstrength.
 6. The enclosure of claim 4, wherein the first peel strengthis great enough to prevent separation of the first cover from the sleevewithout tearing the sleeve.
 7. The enclosure of claim 1, wherein theport is at least one of a charging port or a communication port.
 8. Theenclosure of claim 7, wherein the communication port is a USB port. 9.The enclosure of claim 1, wherein the sleeve comprises a materialselected from the group consisting of polyurethane, polyethylene, andlow density polyethylene.
 10. The enclosure of claim 1, wherein thesleeve comprises a first portion comprising a first material and asecond portion comprising a second material.
 11. The enclosure of claim10, wherein the second material has greater stiffness than the firstmaterial.
 12. The enclosure of claim 10, wherein the first portioncomprises a material selected from the group consisting of polyurethane,polyethylene, and low density polyethylene.
 13. The enclosure of claim10, wherein the second portion comprises a material selected from thegroup consisting of polycarbonate and acrylonitrile butadiene styrene.14. The enclosure of claim 10, wherein the second portion is configuredto provide access to the port.
 15. The enclosure of claim 10, whereinthe first opening is surrounded by the first portion, and wherein thesecond opening is surrounded by the second portion.
 16. The enclosure ofclaim 1, wherein the first opening comprises a first slit that extendsin a longitudinal direction, and a second slit that extends in atransverse direction.
 17. The enclosure of claim 16, wherein a first endof the first slit corresponds to a lengthwise center of the second slit.18. The enclosure of claim 16, wherein the electronic medical device isconfigured to display continuous glucose concentration data over a timeperiod.
 19. A method for reprocessing a reusable electronic medicaldevice, the method comprising: receiving an electronic medical devicefrom a first user, wherein the electronic medical device is contained ina first protective enclosure; removing the electronic medical devicefrom the first protective enclosure; inserting the electronic medicaldevice into a second protective enclosure through an opening in thesecond protective enclosure; adhering a cover to the second protectiveenclosure over the opening; and providing the electronic medical devicecontained within the second protective enclosure to a second user. 20.The method of claim 19, further comprising creating a disinfected field,wherein removing the electronic medical device from the first protectiveenclosure and placing the electronic medical device in a secondprotective enclosure are performed in the disinfected field.
 21. Themethod of claim 19, wherein removing the electronic medical device fromthe first protective enclosure requires tearing the first protectiveenclosure.
 22. The method of claim 19, further comprising cleaning anddisinfecting the electronic medical device.
 23. The method of claim 19,wherein the electronic medical device is configured to displaycontinuous glucose concentration data over a time period.
 24. The methodof claim 19, wherein the cover is configured to prevent separation fromthe second protective enclosure without damaging the second protectiveenclosure.
 25. The method of claim 19, wherein removing the electronicmedical device from the first protective enclosure, inserting theelectronic medical device into a second protective enclosure through anopening in the second protective enclosure, and adhering a cover to thesecond protective enclosure over the opening are performed by anindividual wearing a glove.
 26. The method of claim 25, furthercomprising disposing the glove.